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Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Clinical research trials and Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer. Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer  Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
For Condition: stage 1 ovarian epithelial cancer,stage 3 ovarian epithelial cancer,recurrent ovarian epithelial cancer,stage 2 ovarian epithelial cancer,Fallopian Tube Cancer,peritoneal cavity cancer,stage 4 ovarian epithelial cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have recurrent or persistent ovarian, fallopian tube, or peritoneal cancer.
Details: OBJECTIVES: I. Determine the clinical activity of 6-hydroxymethylacylfulvene in patients with recurrent or persistent ovarian epithelial cancer. II. Characterize the pharmacokinetic profile of this regimen in these patients. III. Determine the pharmacodynamic relationship between plasma concentrations and clinical activity or toxicity of this regimen in these patients. PROTOCOL OUTLINE: This is an open label study. Patients are stratified by the number of prior treatment regimens (1-2 vs 3 or more). Patients receive 6-hydroxymethylacylfulvene (HMAF) IV over 5 minutes on days 1-5. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks until death. PROJECTED ACCRUAL: A maximum of 74 patients will be accrued for this study over 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically documented recurrent or persistent ovarian epithelial cancer, primary fallopian tube cancer, or primary peritoneal cancer; Must have failed prior standard chemotherapy - Measurable disease - No history of brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: Recovered from prior biologic therapy; No prior bone marrow transplantation - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin); No more than 2 prior chemotherapy regimens - Endocrine therapy: Recovered from prior endocrine therapy - Radiotherapy: Recovered from prior radiotherapy; No prior external beam radiation - Surgery: Recovered from prior surgery - Other: At least 1 week since prior antibiotics --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Greater than 2 months - Hematopoietic: Granulocyte count at least 1,500/mm3; Hemoglobin at least 9.0 g/dL (transfusion allowed); Platelet count at least 100,000/mm3 - Hepatic: Bilirubin normal; ALT and AST no greater than 2.5 times normal; PT or PTT no greater than 1.5 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min; Urinalysis normal; BUN normal; Electrolytes normal - Cardiovascular: At least 6 months since prior unstable or newly diagnosed angina pectoris; No myocardial infarction in the past 6 months; No congestive heart failure (New York Heart Association class II-IV) - Pulmonary: No chronic obstructive lung disease requiring oxygen therapy or medication - Other: No medical or surgical complications requiring intervention, such as: Impending bowel obstruction; Active infection; HIV negative; No other life threatening illness; No non-skin malignancy or melanoma within the past 4.5 years except curatively treated second malignancy with low risk of recurrence or surgically cured stage I endometrial cancer; No uncontrolled seizures; Not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GiseleSarosy, Study Chair, National Cancer Institute (NCI)
Medicine Branch
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: CDR0000066696; MB-403,NCI-T98-0030,NCI-98-C-0162
Study Start Date: February 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00019552
Other Fallopian Tube Cancer Studies:
1. Combination Chemotherapy and Surgery in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
2. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer
3. Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
4. Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
5. Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
Related Studies:
Other Fallopian Tube Cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
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